Friday, May 09, 2014Last Update: 4:17 PM PT

Blame for Infant's Death Won't Fall to Inmar

(CN) - Inmar need not face claims that it secretly recalled Johnson & Johnson Infant's Tylenol that made a 2-week-old baby vomit blood until he died, a federal judge ruled. A doctor's suggestion led Stacy Sherfey to give her son Tracen a recommended dose of Infant's Tylenol in Nevada on Feb. 16, 2009, and two more doses the next day, the complaint states. The baby soon started vomiting blood, so his mother took him to the emergency room, and he was later airlifted to Children's Primary Hospital in Salt Lake City, Utah. Tracen died from acute liver failure on Feb. 19, 2009. Stacy and her husband Neil filed suit in Philadelphia against the drug's manufacturers, distributors and retailers - Johnson & Johnson (J&J), McNeil-PPC Inc., Wal-Mart, and Inmar Inc. and its subsidiaries - and several of their senior officials. The Sherfeys claim that, to save money for ads, the officials replaced full-time lab scientists with "contract workers who lacked technical pharmaceutical experience." They allegedly kept selling the faulty meds despite manufacturing defects, adverse event reports, and "glaring warning signals" like a rebuke from the Food and Drug Administration and quality-control issues that McNeil noticed in 2007. The 2012 complaint also alleges that Inmar implemented a "phantom" recall and conducted "market assessments" to determine the risk the defective medicines posed "to prevent parents from switching permanently to less expensive acetaminophen products." Senior U.S. District Judge Robert Kelly dismissed the Sherfeys' claims against Inmar on April 25, citing similar rulings for a multidistrict case and one involving the death of 2-year-old River Moore. The Sherfeys likewise asserted "no allegations in the complaint that the Inmar defendants had influence over the J&J defendants' decision to conduct a 'phantom recall,' and/or decisions regarding the scope of such a recall," Kelly wrote. "The complaint also does not allege that the Inmar defendants had any knowledge of the specific defects affecting the Infants' Tylenol." The complaint also "does not define 'market assessments,' and does not explain why such assessments were unlawful," the ruling states. Indeed, the judge tossed aside the Sherfeys' "sole" proof of the phantom recall: an email wherein McNeil President Peter Luther allegedly "ratified and approved the phantom/stealth recalls/unethical 'market assessments'" on May 27, 2009. "However, it is alleged that Tracen consumed the defective product and died in February 2009," Kelly wrote. "Therefore, we agree with the Inmar defendants that the alleged phantom recall post-dated Tracen's death, and, therefore, could not have caused it." Johnson & Johnson recently announced sales of $18.1 billion for the first quarter of 2014. U.S. District Judge Mary McLaughlin presides over the similar suit filed by Daniel and Katy Moore stemming from the 2010 death of their son, River. U.S. District Judge Gene E.K. Pratter meanwhile presides over the case filed by Shawn Arndt, who says Infant's Tylenol immediately made his 4-year-old bleed from the nose and mouth until he died in November 2009.